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他汀类药物治疗启动与糖尿病进展的关联:一项回顾性匹配队列研究。

Association of Statin Therapy Initiation With Diabetes Progression: A Retrospective Matched-Cohort Study.

机构信息

Department of Medicine, VA North Texas Health Care System, Dallas.

Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.

出版信息

JAMA Intern Med. 2021 Dec 1;181(12):1562-1574. doi: 10.1001/jamainternmed.2021.5714.

Abstract

IMPORTANCE

Statin therapy has been associated with increased insulin resistance; however, its clinical implications for diabetes control among patients with diabetes is unknown.

OBJECTIVE

To assess diabetes progression after initiation of statin use in patients with diabetes.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective matched-cohort study using new-user and active-comparator designs to assess associations between statin initiation and diabetes progression in a national cohort of patients covered by the US Department of Veterans Affairs from fiscal years 2003-2015. Patients included were 30 years or older; had been diagnosed with diabetes during the study period; and were regular users of the Veterans Affairs health system, with records of demographic information, clinical encounters, vital signs, laboratory data, and medication usage.

INTERVENTIONS

Treatment initiation with statins (statin users) or with H2-blockers or proton pump inhibitors (active comparators).

MAIN OUTCOMES AND MEASURES

Diabetes progression composite outcome comprised the following: new insulin initiation, increase in the number of glucose-lowering medication classes, incidence of 5 or more measurements of blood glucose of 200 mg/dL or greater, or a new diagnosis of ketoacidosis or uncontrolled diabetes.

RESULTS

From the 705 774 eligible patients, we matched 83 022 pairs of statin users and active comparators; the matched cohort had a mean (SD) age of 60.1 (11.6) years; 78 712 (94.9%) were men; 1715 (2.1%) were American Indian/Pacific Islander/Alaska Native, 570 (0.8%) were Asian, 17 890 (21.5%) were Black, and 56 633 (68.2 %) were White individuals. Diabetes progression outcome occurred in 55.9% of statin users vs 48.0% of active comparators (odds ratio, 1.37; 95% CI, 1.35-1.40; P < .001). Each individual component of the composite outcome was significantly higher among statin users. Secondary analysis demonstrated a dose-response relationship with a higher intensity of low-density lipoprotein-cholesterol lowering associated with greater diabetes progression.

CONCLUSIONS AND RELEVANCE

This retrospective matched-cohort study found that statin use was associated with diabetes progression, including greater likelihood of insulin treatment initiation, significant hyperglycemia, acute glycemic complications, and an increased number of prescriptions for glucose-lowering medication classes. The risk-benefit ratio of statin use in patients with diabetes should take into consideration its metabolic effects.

摘要

重要性

他汀类药物治疗与胰岛素抵抗增加有关;然而,其对糖尿病患者糖尿病控制的临床意义尚不清楚。

目的

评估糖尿病患者开始使用他汀类药物后糖尿病的进展情况。

设计、地点和参与者:这是一项使用新使用者和活性对照设计的回顾性匹配队列研究,旨在评估美国退伍军人事务部在 2003 年至 2015 年期间全国队列中他汀类药物起始与糖尿病进展之间的关联。纳入的患者年龄在 30 岁或以上;在研究期间被诊断患有糖尿病;并且是退伍军人事务医疗系统的常规使用者,有关于人口统计学信息、临床接触、生命体征、实验室数据和药物使用的记录。

干预措施

开始使用他汀类药物(他汀类药物使用者)或 H2 阻滞剂或质子泵抑制剂(活性对照)治疗。

主要结果和测量

糖尿病进展综合结果包括以下内容:新胰岛素起始、降血糖药物种类增加、血糖 200mg/dL 或更高的测量值 5 次或更多次、酮症酸中毒或未控制糖尿病的新诊断。

结果

在 705774 名合格患者中,我们匹配了 83022 对他汀类药物使用者和活性对照者;匹配队列的平均(SD)年龄为 60.1(11.6)岁;78712(94.9%)为男性;1715(2.1%)为美洲印第安人/太平洋岛民/阿拉斯加原住民,570(0.8%)为亚洲人,17890(21.5%)为黑人,56633(68.2%)为白人个体。在他汀类药物使用者中,55.9%发生了糖尿病进展结局,而在活性对照组中为 48.0%(比值比,1.37;95%CI,1.35-1.40;P < .001)。复合结局的每个个体组成部分在他汀类药物使用者中均显著更高。二次分析显示,与低密度脂蛋白胆固醇降低强度相关的剂量反应关系与更高的糖尿病进展相关。

结论和相关性

这项回顾性匹配队列研究发现,他汀类药物的使用与糖尿病进展有关,包括胰岛素治疗起始的可能性更大、显著高血糖、急性血糖并发症以及降血糖药物种类的处方增加。糖尿病患者使用他汀类药物的风险效益比应考虑其代谢作用。

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